European Trial of Immunosuppression in SPK Tx

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00140543
Recruitment Status : Unknown
Verified August 2005 by EUROSPK Study Group.
Recruitment status was:  Active, not recruiting
First Posted : September 1, 2005
Last Update Posted : November 18, 2005
Fujisawa GmbH
Hoffmann-La Roche
Wyeth is now a wholly owned subsidiary of Pfizer
Neovii Biotech
Genzyme, a Sanofi Company
Information provided by:
EUROSPK Study Group

Brief Summary:
  1. To determine and compare the efficacy of Tacrolimus/Rapa versus Tacrolimus/MMF-based immunosuppression (in conjunction with initial short-term steroids and polyclonal antibody administration) in Type 1-diabetic patients undergoing simultaneous pancreas/kidney allograft transplantation.
  2. To evaluate the safety of Tacrolimus/Rapa versus Tacrolimus/MMF in terms of drug-related complications and overimmunosuppression-associated complications, particularly under monitoring of the pharmacokinetic profile of all drugs administered.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Diabetic Nephropathy Drug: sirolimus versus mycophenolate mofetil Phase 3

Detailed Description:
This will be a controlled, randomised study, to be performed in 15-20 pancreas transplantation centers throughout Europe. Patients will be randomised into one of two treatment groups. Group 1 will receive Tacrolimus and Mycophenolate Mofetil (= best group in EuroSPK001 trial). Group 2 will receive Tacrolimus and Sirolimus. Both groups will receive in association short-term corticosteroids and polyclonal antibody preparation. Patients will be randomly assigned to one of the 2 treatment groups in a 1:1 ratio before transplantation. The study will last 3 years, with a first interim analysis of the data at 6 months and a complete analysis at 1 year.

Study Type : Interventional  (Clinical Trial)
Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A European Multicenter Open-Label Randomised Trial to Evaluate the Efficacy and Safety of Sirolimus and Tacrolimus Compared to MMF and Tacrolimus With Short-Course Induction Therapy, Short-Term Steroids Application in De Novo SPK Transplanted Diabetic Patients
Study Start Date : February 2002
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Primary Outcome Measures :
  1. At 1 year:Incidence of biopsy-proven (kidney) rejection episodes.

Secondary Outcome Measures :
  1. SECONDARY ENDPOINTS: At 6 months and 1 year
  2. * Kidney/Pancreas function (at 6 months and 1 year):
  3. - Kidney function will be measured by:
  4. - S- creatinine
  5. - Creatinine clearance
  6. - Pancreas function will be measured by:
  7. - Fasting Glucose level (< 123 mg/dl)
  8. - HbA1C
  9. - Need for insulin therapy
  10. - Need for oral drugs
  11. * At 6 months and 1 year:
  12. - Patient and graft survival
  13. - Lipid profile
  14. - Infections
  15. - Side effects
  16. - Blood Pressure
  17. - Treatment failure for any reason, such as permanent discontinuation of a drug, graft loss or death.
  18. * % of steroid free patients: at 6 months and 1 year.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female patients, of 18 to 55 years of age, with end-stage, C-peptide-negative, Type 1-diabetic nephropathy.
  2. Female patients of childbearing age must have a negative pregnancy test and must agree to maintain effective birth control practice throughout the study period (3 years).
  3. Patient must have signed the Patient Informed Consent Form.
  4. Patient must receive a primary simultaneous pancreas/kidney (SPK) cadaveric transplant, with either intestinal or bladder and either portal or systemic venous drainages.

Exclusion Criteria:

  1. Patient is pregnant or breastfeeding.
  2. Patient is allergic or intolerant to Mycophenolate Mofetil, Sirolimus, Tacrolimus or other macrolides, or any compounds structurally related to these compounds.
  3. Patient has a positive T-cell crossmatch on the most recent serum specimen.
  4. Patient is known for active liver disease or has significant liver disease, defined by ASAT and ALAT serum levels greater than 3 times the upper limit of normal.
  5. Patient has malignancy or history of malignancy, with the exception of adequately treated localised squamous cell or basal cell carcinoma, without recurrence.
  6. Patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior to randomisation.
  7. Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.
  8. Patient receives a SPK transplant from a living donor, or receives segmental pancreatic transplant, or a previous kidney transplant alone.
  9. Pancreatic duct occlusion technique .
  10. Donor is older than 55 years of age.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00140543

Innsbruck, Austria, 6020
Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
UZ Gent
Gent, Belgium, 9000
UZ Gasthuisberg
Leuven, Belgium, 3000
Czech Republic
Institute for clinical and experimental medicine-IKEM
Prague, Czech Republic, 14021
Charite Campus Virchow Klinikum
Berlin, Germany, 13353
Bochum-Langendreer, Germany, 44892
Goethe University
Frankfurt am Main, Germany, 60590
Chirurgische Universitätsklinik
Freiburg, Germany, 79111
Klinikum Grosshadern-University of Munich
Munich, Germany, 81366
Klinikum Innenstadt der Universität München
Munich, Germany, 90336
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Hospital Clinico
Barcelona, Spain, 08036
Hôpital Cantonal de Geneve
Geneva, Switzerland, 1211
Sponsors and Collaborators
EUROSPK Study Group
Fujisawa GmbH
Hoffmann-La Roche
Wyeth is now a wholly owned subsidiary of Pfizer
Neovii Biotech
Genzyme, a Sanofi Company
Study Chair: Jean-Paul Squifflet, MD,PhD SPEAKER FOR THE EUROSPK STUDY GROUP Identifier: NCT00140543     History of Changes
Other Study ID Numbers: EUROSPK002
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: November 18, 2005
Last Verified: August 2005

Keywords provided by EUROSPK Study Group:
simultaneous pancreas/kidney transplantation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetic Nephropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases
Diabetes Complications
Mycophenolic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antitubercular
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action